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Completed

NCT Number: NCT03375346

Effects of Whole-body Vibration Exercise on Stroke Patients

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.

Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral stroke with hemiplegia
  • 3 months after stroke onset
  • Able to walk at least 10 meters without assistive devices

Exclusion criteria

  • Subjects under 18 years and above 80 years old,
  • Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
  • Musculoskeletal disorders
  • Risk of falling due to dizziness
  • Pregnant women

Treatment and study plan

Whole Body Vibration

Device

whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.

Exercise

Other

maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

Primary outcomes

  1. Cerebral cortex activity

    Time frame: check before, during and directly after intervention(for approximately 14 minutes)

    cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS

Secondary outcomes

  1. 10 meter walk test

    Time frame: before and after intervention(Approximately 14 minutes)

    performance measure used to assess walking speed in metres per second over a short distance. It can be Blender3D NormalWalkCycle.gifemployed to determine functional mobility, gait, and vestibular function.

  2. Timed up and go test

    Time frame: before and after intervention(Approximately 14 minutes)

    test for gait speed and gait balance

  3. Fugl-Meyer Assessment

    Time frame: before and after intervention(Approximately 14 minutes)

    a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

  4. Tinetti Performance Oriented Mobility Assessment

    Time frame: before and after intervention(Approximately 14 minutes)

    Task-oriented outcome measure that assesses gait and balance ability; is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2017
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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